# K972832: Provision Surgical Helmet System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Oct 21, 1997 after 83 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy Sterile View Surgical Exhaust System: named in the summary without a submission number
- (no number) Sterile View Disposable Barrier Hood/Gowns: named in the summary without a submission number
- (no number) DePuy Disposable Filter/Hood: named in the summary without a submission number
- (no number) Stackhouse FreedomAire Surgical Helmet System: named in the summary without a submission number
- (no number) Stryker Steri Shield Turbo III: named in the summary without a submission number

## Recalls of this device
- Jun 27, 2003 · Not classified · Z-1040-03: Lack of assurance of sterility, due to the possibility of an incomplete package seal.
- Jun 27, 2003 · Not classified · Z-1041-03: Lack of assurance of sterility, due to the possibility of an incomplete package seal.
- Jun 27, 2003 · Not classified · Z-1043-03: Lack of assurance of sterility, due to the possibility of an incomplete package seal.

## Indications for use
The ProVision Surgical Helmet System consists of disposable surgical apparel and re-usable headgear, battery holder and battery pack. The ProVision Surgical Helmet System is intended to be worn by healthcare workers in the operating room during surgical prdtedures to protect both the healthcare worker and the surgical patient from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K972832
Methodology: https://510kreport.com/methodology